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Sinus BradycardiaNCT06276816

Cardiac Denervation Ablation Strategy for Severe Sinus Bradycardia

An observational study of Sinus Bradycardia, run by China National Center for Cardiovascular Diseases at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective clinical observation and registration study. The investigator aimed to evaluate the efficacy and safety of cardiac denervation ablation as a treatment strategy for severe sinus bradycardia. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Sinus Bradycardia
How many people
88 participants
Where
1 siteChina
Study dates
13 Sep 2023to 30 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: SSB patients undergoing cardiac denervation ablation

Who may be able to join

  • Sinus bradycardia and pacemaker implantation indication: long interval with mean heart rate <45 bpm or 3s recorded within 6 months before inclusion;
  • Negative atropine test: sinus heart rate> 90bpm after atropine injection
  • SSB related symptoms: dizziness, palpitations, fatigue, amaurosis, syncope, etc.
  • Age ≥18 and <60 years old;
  • The patient has agreed to participate in this trial and has signed the informed consent form.

Who cannot join

  • Previous history of atrial arrhythmia ablation or surgical procedure;
  • Structural heart disease, chronic liver and kidney dysfunction, diabetes mellitus, neurological diseases.;
  • Drug-related SSB;
  • presence of left atrial thrombus;
  • Pregnant women.

Trial locations and contacts

1 site in 1 country.

yan Yao, PhD contact

13901121319

ianyao@263.net.cn

lihui Zheng, PhD contact

13910617612

zhenglihui@263.net

China1 site, 1 recruiting

  • 1Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing

    Yao Yan, MD PhD, +86-1390-1121-319, ianyao@263.net.cn

    Recruiting

Other trials in China

About this study

This is a prospective clinical observation and registration study. The investigator aimed to evaluate the efficacy and safety of cardiac denervation ablation as a treatment strategy for severe sinus bradycardia.

Read the detailed description

Severe sinus bradycardia (SSB) is a common clinical condition that can lead to symptoms such as dizziness, fainting, and even cardiac arrest, posing a serious threat to patients' health and life. The causes of SSB vary: in elderly patients, SSB is often caused by ischemia and degenerative changes in the sinoatrial node, while in younger patients, it is often due to abnormal elevation of vagal nerve tone resulting in slowed heart rate and weakened myocardial contractility. Although implanting a pacemaker can effectively alleviate SSB bradycardia, the incidence of pacemaker electrode-related complications (such as electrode displacement, insulation layer rupture, lead infection, and fracture) is not low. Moreover, the impact of pacemaker implantation on patients' quality of life and the economic burden of regular pacemaker battery replacement impose significant psychological and financial burdens on patients, especially young patients. Clearly, for young SSB patients, if the abnormally elevated vagal nerve tone can be continuously reduced, it would be more effective in treating bradycardia and avoiding pacemaker implantation, which has significant social and economic value.

The investigators has pioneered the technique of cardiac denervation ablation, which can modulate the autonomic nervous tone of the heart and is used to treat autonomic nervous system-related diseases. In a preliminary exploratory study involving 6 SSB patients, investigators found that cardiac denervation ablation for SSB can reduce vagal nerve tone, increase sinus heart rate, and effectively alleviate bradycardia symptoms, thus avoiding the need for pacemaker implantation.

Therefore, based on the preliminary work, this project aims to conduct a prospective observational study and establish a registry. SSB patients who meet the indications for pacemaker implantation will be selected to evaluate the efficacy and safety of cardiac denervation ablation for SSB, its impact on quality of life, and the effectiveness of avoiding pacemaker implantation. The project will establish standardized surgical strategies and protocols for cardiac denervation ablation for SSB, summarize experiences, and lay the foundation for the clinical promotion and guideline revision of catheter ablation for SSB.

Keywords
Sinus Bradycardia, Cardioneuroablation, Sinus Node Dysfunction, Autonomic Nervous System
Medical subject headings
Sick Sinus Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with postoperative recurrence of bradycardia symptoms

    Symptoms such as chest tightness, suffocation, amaurosis, syncope with cardiac arrest with mean heart rate <45bpm or ≥3s on 12-lead ECG or Holter

    Measured: 12 months after ablation procedure

Secondary outcomes (6)

  1. The result of the atropine test

    A negative response was defined as a 25% increase in sinus heart rate or an increase in sinus rhythm to 90 bpm after atropine injection.

    Measured: 12 months after ablation procedure

  2. Changes in quality of life measured by Medical Outcomes Study 36- Item Short Form Health Survey (SF-36)

    Patients' quality of life was assessed by Medical Outcomes Study 36- Item Short Form Health Survey (SF-36). The scale contains 36 items in 9 categories of physical functioning, role-physica, bodily pain, general health, vitality, social functioning, role-emotional, mental health and reported health transition. Subjects' scores ranged from 0 to 900, with higher scores representing better quality of life.

    Measured: 3, 6, 12 months after ablation procedure

  3. Changes in quality of life measured by EuroQol Five Dimensions Questionnaire Visual Analogue Scale (EQ VAS)

    Patients' quality of life was assessed by EuroQol Five Dimensions Questionnaire Visual Analogue Scale (EQ VAS). Subjects' scores ranged from 0 to 100, with higher scores representing better quality of life.

    Measured: 3, 6, 12 months after ablation procedure

  4. Changes in minmum heart rate

    Comparison of postoperative versus baseline minimum heart rate using a 24-hour holter. The device provided to patients prior to discharge or at outpatient visits will be used for this assessment.

    Measured: 3, 6, 12 months after ablation procedure

  5. Changes in mean heart rate

    Comparison of postoperative versus baseline mean heart rate using a 24-hour holter. The device provided to patients prior to discharge or at outpatient visits will be used for this assessment.

    Measured: 3, 6, 12 months after ablation procedure

  6. Changes in deceleration capacity

    Comparison of postoperative versus baseline deceleration capacity (DC) using a 24-hour holter. Higher DC suggest higher vagal activity. The device provided to patients prior to discharge or at outpatient visits will be used for this assessment.

    Measured: 3, 6, 12 months after ablation procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2024
  2. Study start13 Sep 2023
  3. Primary completion30 Sep 2024 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06276816
Sponsor's protocol ID
2022-LC14
Status last verified
Nov 2023
First submitted
2 Jan 2024
Last updated
26 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Shen WK, Sheldon RS, Benditt DG, Cohen MI, Forman DE, Goldberger ZD, Grubb BP, Hamdan MH, Krahn AD, Link MS, Olshansky B, Raj SR, Sandhu RK, Sorajja D, Sun BC, Yancy CW. 2017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Circulation. 2017 Aug 1;136(5):e60-e122. doi: 10.1161/CIR.0000000000000499. Epub 2017 Mar 9. No abstract available.

    PubMed 28280231

  • Brignole M, Moya A, de Lange FJ, Deharo JC, Elliott PM, Fanciulli A, Fedorowski A, Furlan R, Kenny RA, Martin A, Probst V, Reed MJ, Rice CP, Sutton R, Ungar A, van Dijk JG; ESC Scientific Document Group. 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. 2018 Jun 1;39(21):1883-1948. doi: 10.1093/eurheartj/ehy037. No abstract available.

    PubMed 29562304

  • Sun W, Zheng L, Qiao Y, Shi R, Hou B, Wu L, Guo J, Zhang S, Yao Y. Catheter Ablation as a Treatment for Vasovagal Syncope: Long-Term Outcome of Endocardial Autonomic Modification of the Left Atrium. J Am Heart Assoc. 2016 Jul 8;5(7):e003471. doi: 10.1161/JAHA.116.003471.

    PubMed 27402231

  • Hu F, Zheng L, Liang E, Ding L, Wu L, Chen G, Fan X, Yao Y. Right anterior ganglionated plexus: The primary target of cardioneuroablation? Heart Rhythm. 2019 Oct;16(10):1545-1551. doi: 10.1016/j.hrthm.2019.07.018. Epub 2019 Jul 19.

    PubMed 31330187

  • Hu F, Zheng L, Liu S, Shen L, Liang E, Liu L, Wu L, Ding L, Yao Y. The impacts of the ganglionated plexus ablation sequence on the vagal response, heart rate, and blood pressure during cardioneuroablation. Auton Neurosci. 2021 Jul;233:102812. doi: 10.1016/j.autneu.2021.102812. Epub 2021 Apr 20.

    PubMed 33940549

  • Hu F, Zheng L, Liu S, Shen L, Liang E, Ding L, Wu L, Chen G, Fan X, Yao Y. Avoidance of Vagal Response During Circumferential Pulmonary Vein Isolation: Effect of Initiating Isolation From Right Anterior Ganglionated Plexi. Circ Arrhythm Electrophysiol. 2019 Dec;12(12):e007811. doi: 10.1161/CIRCEP.119.007811. Epub 2019 Nov 25.

    PubMed 31760820

  • Tu B, Wu L, Hu F, Fan S, Liu S, Liu L, Ding L, Zheng L, Yao Y. Cardiac deceleration capacity as an indicator for cardioneuroablation in patients with refractory vasovagal syncope. Heart Rhythm. 2022 Apr;19(4):562-569. doi: 10.1016/j.hrthm.2021.12.007. Epub 2021 Dec 9.

    PubMed 34896621

  • Zheng L, Sun W, Qiao Y, Hou B, Guo J, Killu A, Yao Y. Symptomatic Premature Ventricular Contractions in Vasovagal Syncope Patients: Autonomic Modulation and Catheter Ablation. Front Physiol. 2021 May 3;12:653225. doi: 10.3389/fphys.2021.653225. eCollection 2021.

    PubMed 34012407

  • Stavrakis S, Scherlag BJ, Po SS. Autonomic modulation: an emerging paradigm for the treatment of cardiovascular diseases. Circ Arrhythm Electrophysiol. 2012 Apr;5(2):247-8. doi: 10.1161/CIRCEP.112.972307. No abstract available.

    PubMed 22511657

  • Zhao L, Jiang W, Zhou L, Wang Y, Zhang X, Wu S, Xu K, Liu X. Atrial autonomic denervation for the treatment of long-standing symptomatic sinus bradycardia in non-elderly patients. J Interv Card Electrophysiol. 2015 Aug;43(2):151-9. doi: 10.1007/s10840-015-9981-8. Epub 2015 Feb 19.

    PubMed 25693516

  • Qin M, Zhang Y, Liu X, Jiang WF, Wu SH, Po S. Atrial Ganglionated Plexus Modification: A Novel Approach to Treat Symptomatic Sinus Bradycardia. JACC Clin Electrophysiol. 2017 Sep;3(9):950-959. doi: 10.1016/j.jacep.2017.01.022. Epub 2017 Apr 26.

    PubMed 29759719

  • Debruyne P, Rossenbacker T, Collienne C, Roosen J, Ector B, Janssens L, Charlier F, Vankelecom B, Dewilde W, Wijns W. Unifocal Right-Sided Ablation Treatment for Neurally Mediated Syncope and Functional Sinus Node Dysfunction Under Computed Tomographic Guidance. Circ Arrhythm Electrophysiol. 2018 Sep;11(9):e006604. doi: 10.1161/CIRCEP.118.006604.

    PubMed 30354289

  • Debruyne P, Rossenbacker T, Janssens L, Collienne C, Ector J, Haemers P, le Polain de Waroux JB, Bazelmans C, Boussy T, Wijns W. Durable Physiological Changes and Decreased Syncope Burden 12 Months After Unifocal Right-Sided Ablation Under Computed Tomographic Guidance in Patients With Neurally Mediated Syncope or Functional Sinus Node Dysfunction. Circ Arrhythm Electrophysiol. 2021 Jun;14(6):e009747. doi: 10.1161/CIRCEP.120.009747. Epub 2021 May 17.

    PubMed 33999698

Questions about this trial

What is this clinical trial studying?

An observational study of Sinus Bradycardia, run by China National Center for Cardiovascular Diseases at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact yan Yao, PhD (13901121319, ianyao@263.net.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with postoperative recurrence of bradycardia symptoms (time frame: 12 months after ablation procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06276816, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.

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